Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company, announces that three abstracts have been accepted for poster presentations at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting taking place from May 4 to 8 in Salt Lake City, UT.
These posters present clinical data related to the STAR Study, Sydnexis’ groundbreaking pivotal phase 3 clinical trial evaluating SYD-101, a novel and proprietary low-dose atropine formulation to slow the progression of pediatric myopia. Two of the posters feature baseline methodologies and a 36-month analysis of myopia progression in a globally diverse population of 282 patients. The third poster highlights the benefits of SYD-101.
“We are pleased to share what makes SYD-101’s proprietary formulation novel in our landmark STAR Study, which is the largest ever clinical trial completed for the treatment of slowing the progression of pediatric myopia,” said Patrick Johnson, Ph.D., President at Sydnexis. “We look forward to this first of many opportunities to engage with the broader ophthalmology community about how the landmark study may impact future treatment paradigms for the growing pediatric myopia epidemic.”
Sydnexis recently announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SYD-101 and assigned a PDUFA target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option available in the United States for the treatment of the progression of pediatric myopia.
Abstract and Poster Details
Title: The natural history of myopia progression in a large diverse pediatric population.
Lead Author: Janet K. Cheetham, Pharm.D., Sydnexis Inc. et al
Date: Tuesday, May 6, 2025
Location: Calvin L. Rampton Salt Palace Convention Center Poster Hall
Poster: A0117
Title: Methods and baseline of a large, multi-center, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study).
Lead Author: Patrick Johnson, Ph.D., Sydnexis Inc. et al
Date: Tuesday, May 6, 2025
Location: Calvin L. Rampton Salt Palace Convention Center Poster Hall
Poster: A0118
Title: Effect of pH and BAK in low-dose atropine on pupil dilation in dutch belted rabbits.
Lead Author: Tim Murphy, M.S., Sydnexis Inc. et al
Date: Tuesday, May 6, 2025
Location: Calvin L. Rampton Salt Palace Convention Center Poster Hall
Poster: A0132
About Pediatric Myopia:
Myopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. By 2050, global prevalence is projected to increase and affect more than 740 million children and adolescents and 5 billion people in total. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening comorbidities later in life.
About Sydnexis, Inc.:
Founded in 2014, Sydnexis, Inc. (www.sydnexis.com) is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital.
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